ARPA-H SSO: “AGENTIC AI-ENABLED CARDIOVASCULAR CARE TRANSFORMATION” (ADVOCATE)

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

ARPA-H is now accepting proposals for ADVOCATE: Agentic AI-Enabled Cardiovascular Care Transformation, a major new Innovative Solutions Opening (ISO) focused on deploying autonomous, FDA-regulated clinical AI agents for cardiovascular disease (CVD) care at national scale.

This program is designed to fund teams that can build, validate, and deploy patient-facing AI agents, paired with independent supervisory AI, and integrate them directly into real healthcare systems. Selected performers will work closely with FDA, large health systems, and ARPA-H leadership to establish a blueprint for scalable, reimbursable agentic AI in healthcare. A Solution Summary is mandatory and is due February 27, 2026, at 5:00 PM EST. Full proposals are by invitation only and are due April 1, 2026, at 5:00 PM EST.

How much funding would I receive?

• Total award size: Not specified in the solicitation

• Number of awards: Multiple awards anticipated

• Funding mechanism: Other Transaction (OT) Agreements

• Program length: Up to 39 months

  • Phase 1A: 12 months

  • Phase 1B: 12 months (option)

  • Phase 2: 15 months (option)

What could I use the funding for?

Funding must support development, validation, and deployment of agentic AI systems for cardiovascular care, aligned to one or more of the following Technical Areas (TAs):

TA1 — CVD Agent (Patient-Facing Clinical AI)

• Autonomous or semi-autonomous AI agents that:

  • Provide diagnostic and treatment assistance

  • Adjust prescriptions for CV conditions (FDA medical device)

  • Integrate real-time EHR and wearable data

  • Deliver 24/7 outpatient care management

• Clinical reasoning using multimodal inputs (text, voice, image, video)

• FDA regulatory engagement and authorization

• Deployment into real health systems for scalability studies

TA2 — Supervisory Agent (AI Oversight & Control)

• Disease-agnostic AI that:

  • Monitors safety, accuracy, uncertainty, and risk of clinical AI

  • Enables real-time control and auditability

  • Supports FDA Medical Device Development Tool (MDDT) qualification

• Continuous post-market monitoring functionality

• Strong preference for open-source solutions

TA3 — Scaled Implementation (Health Systems Only)

• Integration of TA1 and TA2 agents into live clinical workflows

• Access to EHR production and pre-production environments

• Execution of large-scale Scalability Studies

• Clinical outcome, cost, and reimbursement evidence generation

Are there any additional benefits I would receive?

Selected teams receive:

• Direct engagement with FDA throughout development

• Access to real EHR data, clinicians, and patients (via TA3 performers)

• Participation in large, ARPA-H-funded scalability studies

• Validation by an independent IV&V partner

• Visibility with payers and CMS-relevant evidence generation

• Potential facilitation of investor engagement by ARPA-H

What is the timeline to apply and when would I receive funding?

Key dates (firm):

• Posting date: January 13, 2026

• Proposers’ Day: January 23, 2026 (8:30 AM – 5:00 PM EST)

• Proposers’ Day registration deadline:

  • In-person: January 21, 2026, at 5:00 PM EST

  • Virtual: January 21, 2026, at 5:00 PM EST

• Solution Summary due: February 27, 2026, at 5:00 PM EST

• Full proposal due (if invited): April 1, 2026, at 5:00 PM EST

Funding timing after submission is not specified and is contingent on negotiations and down-selection decisions.

Where does this funding come from?

• Agency: Advanced Research Projects Agency for Health (ARPA-H)

• Office: Scalable Solutions Office (SSO)

• Authority: Other Transaction (OT)

Who is eligible to apply?

Eligible applicants include:

• U.S. startups and growth-stage companies

• Universities and academic teams

• Non-profit organizations

• Non-federal research organizations

Not eligible:

• Federally Funded Research and Development Centers (FFRDCs)

• Federal government entities or employees (as performers)

• Entities from covered foreign countries or foreign entities of concern

• Organizations with unmitigable ARPA-H conflicts of interest

TA3 applicants cannot apply to TA1 or TA2.

What companies and projects are likely to win?

ARPA-H is explicitly seeking teams that:

• Are building agentic (not rules-based) clinical AI

• Can meet FDA medical device or MDDT requirements

• Have real experience integrating with EHRs and health systems

• Can demonstrate a path to non-inferiority vs cardiologists

• Are prepared for open data sharing and multi-party collaboration

• Can scale beyond pilots into national deployment

Incremental clinical decision support tools are unlikely to be competitive.

Are there any restrictions I should know about?

Key restrictions include:

• Foundation models cannot be developed from scratch

• Solutions must be interoperable with other agents

• Clinical AI must pursue FDA authorization or qualification

• Extensive data-sharing and collaboration are mandatory

• Foreign talent, ownership, or funding risks are heavily scrutinized

• TA1 and TA2 proposals must remain technically independent

How long will it take me to prepare an application?

• Solution Summary: ~2–4 weeks for competitive teams

• Full Proposal: ~6–10 weeks if invited

Team formation, regulatory strategy, and data architecture must be addressed early.

How can BW&CO help?

BW&CO helps teams:

• Translate ADVOCATE requirements into a clear, fundable narrative

• Position technical capabilities against TA-specific metrics

• Shape FDA and commercialization strategy language

• Design compliant multi-party teaming structures

• Avoid common ARPA-H disqualifiers

How much would BW&CO Charge?

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

Review the solicitation here.